Atraumatic circumcision apparatus and method of using same

ABSTRACT

A disposable neonatal circumcision device that secures the foreskin of the penis in a precise location, applies radially circumferential clamping, and delivers a longitudinal circumferential cutting device along the path precisely controlled by the device itself, not the operator, ensuring the incision to the clamped foreskin is made in the precise location, independent of the operator.

CROSS REFERENCE TO RELATED APPLICATIONS

The present invention claims benefit of U.S. Provisional ApplicationSer. No. 61/121,415, entitled “ATRAUMATIC CIRCUMCISION APPARATUS ANDMETHOD” filed on Dec. 10, 2008, and is a Continuation In PartApplication of U.S. Non-Provisional application Ser. No. 11/768,808,entitled “SELF-ADJUSTING PRESSURE APPLICATOR” filed Jun. 26, 2007, whichclaims benefit of U.S. Provisional Application Ser. No. 60/816,798,entitled “SELF-ADJUSTING PRESSURE APPLICATOR” filed on Jun. 26, 2006,and is a Continuation In Part Application of U.S. Non-Provisionalapplication Ser. No. 11/571,120, entitled “ATRAUMATIC CIRCUMCISIONAPPARATUS AND METHOD” filed May 14, 2007, which is a 371 ofPCT/US05/22404, entitled “ATRAUMATIC CIRCUMCISION APPARATUS AND METHOD”filed Jun. 23, 2005, which claims benefit of U.S. ProvisionalApplication Ser. No. 60/583,259, entitled “ATRAUMATIC CIRCUMCISION RINGAND METHOD” filed on Jun. 25, 2004, all are incorporated herein byreference which is incorporated herein by reference.

FIELD OF THE INVENTION

The present invention is related generally to the field of circumcision,and more particularly to a method and device for neonatal circumcisionenabling surgical removal of the excess foreskin or prepuce from theneonatal penis by a non-traumatic approach, eliminating the need for thetraditional dorsal slit.

BACKGROUND OF THE INVENTION

Newborn circumcision is the most commonly performed surgical procedurein the United States with over 1 million circumcisions performedannually. Circumcisions have been performed for centuries for bothreligious and medical reasons. Various instruments have been developedto help facilitate removal of the foreskin from the penis. Theseinstruments were intended to provide some level of hemostasis to helpcontrol bleeding, to provide a uniform cutting surface, and to protectthe underlying glans penis from trauma associated with the procedure. Ofthese devices, three are commonly used for neonatal circumcision in theUnited States: U.S. Pat. No. 119,180 ('180) by A. A. Goldstein, U.S.Pat. No. 2,747,576 ('576) by H. Bronstein, and U.S. Pat. No. 2,272,072('072) by C J. Ross and U.S. Pat. No. 3,056,407 ('407) by D. H. Kariheret al.

One shortcoming of all the prior art is that a dorsal slit in theforeskin is required. In a neonate, the opening of the foreskin at thetip of the penis is small and tight. A dorsal slit is made to freeadhesions or separate the foreskin from the penis, allow enough room toaccommodate a cutting surface, and to facilitate alignment of a cuttingtool. This procedure causes a traumatic incision to be made on thedorsal surface of the foreskin, perpendicular to and unrelated to thefinal incision. In order to create the dorsal slit, considerable traumais exerted to the foreskin and to the neonate.

In order to initiate the dorsal slit, it is necessary to grasp theforeskin. In practice, this is routinely done with two hemostats thatare used to clamp and crush the distal foreskin at the ten o'clockposition and the two o'clock position. By clamping and thereforecrushing the foreskin, the surgeon is able to apply counter tractionwith one hand holding both instruments, while the surgeon uses the freehand to manipulate a third, straight hemostat to probe under theforeskin and then crush along the dorsal aspect. Scissors are used tocut the dorsal slit where the tissue was crushed. In order to create thedorsal slit, the foreskin of the newborn infant is unnecessarily crushedmultiple times and cut.

Studies published by the American Academy of Pediatrics state that amajority of circumcisions are done without any form of anesthesia. Thedorsal slit incision accounts for a significant amount of the pain andtrauma associated with a circumcision. In addition, the dorsal slit canbe a source for significant bleeding and possible infection.Additionally, the Food and Drug Administration (FDA) regularly reportscases where when attempting to perform the dorsal slit the surgeoninadvertently inserts the tip of the scissors into the urethral meatusand cuts not only through the foreskin but the glans penis itself.

The most commonly used neonatal circumcision clamp is described in U.S.Pat. No. 119,180 ('180) by A. A. Goldstein (referred to herein as theGomco). It consists of a metallic bell that is used to cover the glansor head of the penis to provide protection. After the dorsal slit ismade as described above, the foreskin is pulled over the bell and thebell is advanced upward through a hole that serves as a clampingsurface. A fulcrum and a screw nut are used to apply a force between theclamp and the bell, which crushes the foreskin and serves to helpcontrol bleeding during the incision. One of the shortcomings of theGomco is the difficulty to pull the foreskin up through the clampbecause of the small hole and the size of the clamp. It is a commonpractice for surgeons using the Gomco to use a common safety pin topierce the foreskin of the penis on either side of the dorsal slit tohold the foreskin together and to facilitate pulling the foreskin intothe clamp. Piercing the foreskin twice with a sharp, large needlegenerates unnecessary pain and increases the possibility of bleeding andtraumatic complications. Yet another shortcoming of the Gomco is thatthe bell is separate from the clamp making it possible to use the wrongsize bell with the wrong size clamp. Traumatic complications, includingpenile amputations, have been caused because of this mismatch of belland clamp. Furthermore, it is awkward to manipulate the large clamp andto attempt to pull the foreskin through the small bell opening whileengaging the clamping mechanism. Lastly, the final incision is made withthe free hand of the surgeon with a conventional scalpel attempting tocut around the bell. This procedure imposes a possibility of inadvertentplacement of the scalpel in the wrong position with associatedcatastrophic outcomes, such as penile amputation.

Another commonly used circumcision device is described in U.S. Pat. No.2,272,072 by Ross and U.S. Pat. No. 3,056,407 by Kariher et al.(referred to herein as the Plastibell), which also requires thetraumatic dorsal slit. The Plastibell employs a plastic bell that istied off with a string in a form of tourniquet. The remaining foreskinis trimmed with scissors. The plastic handle of the bell is broken offand the plastic bell stays in place until the foreskin necrosis andfalls off The most reported complication of the Plastibell is increasedinfections due to the foreign body nature of the plastic bell, string,and necrotic tissue. Many parents object to this method, because they donot want to have to worry about the plastic bell that stays in place forup to 5 days following the circumcision. Another shortcoming is that thestring can be cut inadvertently by the surgeon performing thecircumcision causing excessive bleeding. The string can also be tiedwith insufficient applied pressure to prevent bleeding. As with theGomco, the chance for damage to the urethral opening of the glans ispossible because the surgeon makes the incision with scissors. Lastly,it is very difficult and awkward to simultaneously hold the plastic bellin place, keep the foreskin together, and tie a knot in the string atthe precise location on the plastic bell.

Yet another circumcision device is described in U.S. Pat. No. 2,747,576('576) by H. Bronstein (referred to herein as the Mogen clamp). TheMogan clamp is used less frequently because it is difficult to ensurethat excessive foreskin or the head of the penis has not beeninadvertently pulled up into the clamp. If the head of the penis isinadvertently pulled up into the clamp, the resulting clamping andincision causes an amputation of the tip of the penis. The FDA hasissued several warnings regarding this shortcoming of the Mogen clamp.Furthermore, the cosmetic outcome is often that the remaining foreskinis lopsided and asymmetric because the incision is made in a lineardirection and the underlying tissue has a circumferential orientation.

In August of 2000, the FDA released a cautionary statement regarding theGomco and Mogen type clamps. The FDA reported receiving 105 reports ofinjuries involving circumcision clamps between the months of July 1996and January 2000 or approximately 30 injuries per year. Assuming asimilar injury rate for the preceding 54 years, when these devices wereinitially introduced, they have likely accounted for well over 1600traumatic outcomes. Those incidents reported by the FDA includedlacerations, hemorrhages, penile amputations, and urethral damage.

U.S. Pat. No. 3,072,126 by P. M. Fenton ('126) discloses the use of anaxial circular cutting means to apply hemostasis compression to theforeskin as well as to cut the foreskin. The axial compression forceapplied by the circular cutting means to crush the foreskin invariablystretches and deforms the foreskin. As the circular cutting means isengaged, the foreskin is frequently and inappropriately pushed down overthe bell or tube making it difficult to predict the length of foreskinto be removed. Since the same surface is used to cut the foreskin aswell as to create the hemostatic crush to the foreskin, it would bedifficult to ensure that the foreskin is not inadvertently cut prior tothe application of enough compressive pressure to achieve hemostasisleaving the possibility of dangerous bleeding complications. Further,'126 requires use of a bell or tube to shield the glans, necessitatingthe inherent need for a dorsal slit to be made in the foreskin tofacilitate the placement of the foreskin on to the bell or tube.

U.S. Pat. No. 3,473,533 by J. C. Freda ('533) discloses the use of anaxial circular cutting means to cut the foreskin after an axiallyapplied force creates a compressive force for hemostasis. The axialcompression force to crush the foreskin invariably stretches and deformsthe foreskin as the clamping member is applied. As the clamping memberis engaged, the foreskin is frequently inappropriately pushed down overthe bell or tube making it difficult to predict the length of foreskinto be removed. The incision to the foreskin is made independent of thecrush which leaves open the dangerous possibility that an operator caninadvertently administer the cut without having first clamped theforeskin to create hemostasis. Further, '533 requires use of a bell ortube to shield the glans, necessitating the inherent need for a dorsalslit to be made in the foreskin to facilitate the placement of theforeskin on to the bell or tube.

A particular shortcoming shared by the prior art references is that nonedisclose a means to prevent the possibility of mismatched parts. Thepossibility of mismatched equipment or the use of a small shield with alarge clamp has caused dangerous catastrophic outcomes as regularlyreported by the FDA. These injuries are severe and include lacerationsand penile amputations.

SUMMARY OF THE INVENTION

The present invention generally includes two cooperating components: aring component and a clamping-cutting device. One embodiment of the ringcomponent includes an open circular ring mounted to one end of a shaft.One embodiment of the clamping-cutting device includes a plurality ofretractable arms operably connected to at least one movable lever arm.The clamping-cutting device also includes a cutting device (such as acircular blade) disposed within the clamping-cutting device, which isalso operably connected to a lever arm. The shaft of the ring componentmay include a notch in a predetermined location to engage theclamping-cutting device to ensure precise positioning of theclamping-cutting device in relation to the open circular ring. The opencircular ring may also include a circumferential groove along the outersurface of the open circular ring adapted to receive the edges of theretractable arms.

In operation, the ring component is manipulated between the foreskin andthe penis and positioned just above the glans of the penis. The openring allows insertion of the ring component into the foreskin withoutmaking a dorsal slit. This provides the placement of a clamping andcutting surface within the foreskin without making the unnecessary andtraumatic dorsal slit. Once the open ring is placed within the foreskinwithout making a dorsal slit, the clamping-cutting device is placed ontothe shaft of the ring component. The clamping-cutting device is thenactivated by moving the lever arm from the open to closed position. Asthe lever arm is moved downward or toward the closed position, theclamping-cutting device is moved over the plurality of retractable armscausing the arms to move radially inward to the closed position exertinga lateral, symmetric clamping force to the ring that serves to crush theforeskin. By exerting a lateral, symmetrical force, no manipulation ordeformation of the foreskin has to occur to get it into the clamp. Thering is positioned within the foreskin and remains in that locationuntil the lateral clamping force is applied. There is no need to pull ormanipulate the foreskin to get it into the clamp. The clamp is deliveredlaterally and symmetrically to the foreskin and ring so there is nodeformation to the foreskin prior to it being crushed, ensuring a moreprecise, reproducible, and predictable circumcision. In the closedposition, the plurality of retractable arms close on to and engage theopen circular ring, thereby closing the ring and crushing or clampingthe foreskin against the now closed circular ring. At the moment thecrush occurs, the foreskin remains in its anatomically correct position,improving the likelihood the physician can accurately determine thecorrect amount of foreskin to remove. Continued movement of the leverarm advances the cutting device towards the circular ring that cuts theforeskin clamped between the retractable arms and the circular ring.

One aspect of the present invention adapts a cutting device (such as ablade) to an actuator such that the cutting device translates parallelwith the shaft of the penis when cutting the foreskin. The mechanicalactuation of the cutting device provides an improvement in the controlof the position of the cutting device relative to the shaft of thepenis. The cutting device preferably translates along the common axis ofthe actuator which in turn translates along the common axis of the shaftof the ring component. The shaft of the ring component facilitatestranslation of the clamping-cutting device along the common axisproviding control of the positioning and alignment of the cutting devicewith the compression and cutting surface of the ring component. Theposition of the shaft in relation to the compression and cutting surfaceis fixed such that the cutting device can only reach the exact locationof the cutting surface, protecting surrounding tissue and eliminatingany chance of inadvertent damage to the penis from the cutting blade.The blade is an integral part of the device, the incision can not bemade until the housing has closed the retractable arms ensuring adequateclamping and crushing. The path of the blade is precisely controlled bythe device itself, not the operator, ensuring the incision is made inthe precise location, independent of the operator. The design of thepresent invention essentially eliminates the possibility of making anincision without having adequately crushed the foreskin. With thisdevice, the timing of the crush and cut is precisely controlled, theincision can not occur without first crushing the foreskin.

Another aspect of the present invention is that the blade is containedand protected within the device itself, essentially eliminating thechance of inadvertent trauma to surrounding structures.

Another aspect of the present invention is that the internal shape ofthe opening of the clamping-cutting device can be made such that it canonly mate with an appropriate ring. Anatomic variation requires devicesof different size. This requires different size housings and differentsize rings. In order to completely eliminate the chance of usingmismatched parts, the housing and ring will be uniquely mated, so thatonly the exact housing can be used with a particular sized ring. Thismechanical specification will eliminate any chance of a userinadvertently using the wrong size ring with the wrong sizeclamping-cutting device. The design of this invention eliminates thepossibility of mismatched parts and their potential catastrophicoutcomes.

Another aspect of the present invention is that the open ring can bemade to interact with the clamping-cutting device such that a mechanicalstop can be used to control when and how the levers are activated. Byusing a mechanical stop, the two parts can be designed such that thelever arms can not be activated unless the clamping-cutting device ispositioned in the exact position on the ring that inhibits themechanical stop. This type of interaction can ensure that theclamping-cutting device can only be placed on the ring when in the openposition, and the lever arms can only be activated when theclamping-cutting device is in the exact position on the ring.Furthermore, the design makes it impossible to move the housing once thelever arms have been activated, eliminating the chance of the operatorpulling off the housing prior to completion of the crushing and theincision. The design ensures that the only way the operator can put theclamping-cutting device on the shaft of the ring is in the openposition, eliminating the chance of the operator erroneously putting theclamping-cutting device on in the closed position. Furthermore, thedesign eliminates the chance of the operator activating the lever armsbefore the clamping-cutting device is in the exact location. It can alsoeliminate the chance of the clamping-cutting device moving at all alongthe shaft once the lever arms have been activated. The mechanicalcontrol of these important procedural elements ensures a reproducible,risk free circumcision, independent of the operator.

Other embodiments of the invention include a closed ring, tongue andgroove clamp arm members, housing extension, lever arm lockingmechanism, visual ring engagement indicator, slip gear and safetymechanism.

It is an object of the present invention to provide a device to easilyperform newborn circumcision, shorten the operation time, producereliable and consistent outcomes, and substantially eliminate the riskof human error and catastrophic outcomes.

It is a further object of the present invention to provide a device toperform neonatal circumcision that eliminates the need for thetraditional dorsal crush and slit, thereby minimizing bleeding andsignificantly reducing the trauma and pain associated with theprocedure.

It is a further object of the present invention to provide a device thatdelivers a lateral, symmetrical clamping force to the foreskin and thering thereby eliminating the need to pull or manipulate the foreskin toposition it in the clamping means.

It is a further object of the present invention to provide a device thatfacilitates the use of a circular cutting device that is deliveredlongitudinally to the shaft of the penis and performs a singlecircumferential and uniform incision.

It is a further object of the present invention to provide a device thatintegrates and encloses the circular blade within the device such thatthe device itself provides precise control over the delivery of thecutting surface while protecting the patient and user from inadvertentinjury, essentially eliminating the chance of user error andcatastrophic complications.

It is a further object of the present invention to provide a device thatadapts a mechanical means to control the crushing of the foreskin andthe delivery of the blade, ensuring that the incision can only be madeafter the foreskin has been sufficiently crushed.

It is a further object of the present invention to provide a mechanicalmeans that completely eliminates the chance of mismatching differentsized parts, eliminating the chance of a ring component being used withthe wrong sized crushing-cutting device.

It is a further object of the present invention to use a lever arm withsemicircular gears and a gear track to activate device.

It is a further object of the present invention to have the ability tomanufacture each of the non-cutting surface parts out of plasticmaterials allowing the device to be disposable or recyclable for onetime use, eliminating the need for autoclaving, reducing the risk ofmismatched parts, and reducing the risks associated with using worn ordamaged parts.

It is a further object of the present invention for the various sizedparts to be made in differing colors based on size to assist users inidentifying appropriate parts and appropriate sizes, expediting theprocedure, and further avoiding the chance of mismatched parts.

It is a further object of the present invention to incorporate amechanical means or lever locking system that ensures the levers thatactivate the device can only be activated when precise alignment of thering and the clamping-cutting device has been achieved. And suchmechanical means ensures the position of ring and clamping-cuttingdevice is maintained throughout the actuation of the device.

It is a further object of the present invention to generate an audiblesound when the lever arms have been successfully actuated to inform theoperator that the crushing and cutting actions have been completed.

For a better understanding of the present invention, together with otherand further objects thereof, reference is made to the accompanyingdrawings and detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is illustratively shown and described in referenceto the accompanying drawings, in which:

FIG. 1 is an exploded view of the present invention;

FIG. 2 is a cross-section of the present invention of FIG. 1 in theopened or relaxed position;

FIG. 3 is a cross-section of the present invention of FIG. 1 in theclosed or engaged position;

FIG. 4 is a pictorial view of one embodiment of the clamping-cuttingsurface apparatus of the present invention;

FIGS. 5, 6, 7, and 8 are pictorial views of the clamp-cutting apparatusbeing inserted into the foreskin of the neonatal penis;

FIG. 9 are pictorial views illustrating use of the present invention;

FIGS. 10, 11, and 12 are cross sectional views of various embodiments ofthe present invention illustrating insertion of various sizedclamp-cutting surface apparatus into a clamping-cutting device;

FIGS. 13 and 14 are pictorial views of an alternative embodiment of thepresent invention;

FIGS. 15 and 16 are cross section views of another alternativeembodiment of the present invention;

FIG. 17 is a cross section view of yet another alternative embodiment ofthe present invention;

FIG. 18 is an exploded view of the alternative embodiment of FIG. 17;

FIG. 19 is a cross section view of yet another alternative embodiment ofthe present invention;

FIG. 20 is an exploded view of the alternative embodiment of FIG. 19.

FIG. 21A is a perspective view of one embodiment of the presentinvention shown in the up position or disengaged;

FIG. 21B is a perspective view of one embodiment of the presentinvention shown in the down or engaged position;

FIG. 22 is a perspective view of an exemplary foreskin holder of thepresent invention of FIG. 1;

FIGS. 23A-B are side views of the foreskin holder of FIG. 22;

FIG. 23C is a bottom view of the foreskin holder of FIG. 22;

FIGS. 24A-C illustrate the assembly of the foreskin holder of FIG. 22 onto an exemplary embodiment of the ring component;

FIGS. 25-28 are pictorial views of the ring component being insertedinto the foreskin of a penis;

FIGS. 29A-C illustrate the positioning of foreskin between the foreskinholder and the ring component of FIGS. 24A-C;

FIG. 30 are pictorial views illustrating use of the open ring of thepresent invention with a clamping-cutting device;

FIG. 31A illustrates a cross section of the foreskin being held inposition by the present invention prior to clamping and cutting by theclamping-cutting device of FIG. 30;

FIG. 31B illustrates a cross section in the crushing and cuttingposition.

FIG. 31C demonstrates a bottom view of just the retractable arms in theopen, neutral, pre-clamping position.

FIG. 31D demonstrates a bottom view of just the retractable arms in theclosed, clamping position.

FIGS. 32A is an illustration of the present invention of FIG. 21 adaptedfor use with a conventional circumcision clamp;

FIG. 32B is an illustration of the present invention of FIG. 21 adaptedfor use with a conventional circumcision bell.

FIGS. 33A-B are pictorial views of a closed ring embodiment;

FIG. 34 are pictorial views illustrating use of the closed ring of thepresent invention with a clamping-cutting device;

FIGS. 35A-B are pictorial views of the housing of the present inventionof one embodiment of a housing extension;

FIG. 36 is a pictorial of one embodiment of a visual indicator on thering to indicate when the ring is fully engaged in the housing of thepresent invention;

FIGS. 37A-B are pictorial views of one embodiment of the inventiondisengaged and locked in the engaged position;

FIG. 38A is a pictorial view of one embodiment of the lever arm lockingmechanism engaged illustrating a locked position;

FIG. 38B is a pictorial view of one embodiment of the lever arm lockingmechanism illustrating the depression of a tab disengaging the lever armfrom a locked position;

FIGS. 39A-E are sectional views of one embodiment of the presentinvention illustrating embodiments of a slip gear and safety mechanismto provide for proper advancement of the clamp slide tube and blade;

FIGS. 39F-G are pictorial views of one embodiment of the presentinvention having a slip gear and safety mechanism of FIGS. 39A-Eillustrating the lever arm actuation and rotational travel when the ringshaft is properly inserted into the present invention;

FIG. 40 is an exploded view of the present invention illustrated inFIGS. 39A-G; and

FIGS. 41 and 42A-C illustrate examples of varying diameters of thelimiting section of the clamp and varying diameter of the limitingsection of the ring component.

DETAILED DESCRIPTION OF THE INVENTION

One aspect of the present invention 100, illustrated in FIGS. 1, 2, and3, includes ring component 1 and clamping-cutting device 102.Clamping-cutting device 102 includes operably connected housing 2,clamping member 3 with retractable arms 3F, blade holder 4 with integralblade 8, gear track 5, and two lever arms 6. Clamping member 3 isoperably connected to lever arms 6 such that when lever arms 6 areactuated up retractable arms 3F are positioned out of clamping-cuttingdevice 102 to the opened or resting position (FIG. 2) or when lever arms6 are actuated down the clamping-cutting device 102 traverses over theclamping member 3 to the closed or engaged position (FIG. 3).

In the open position (FIG. 2), the ring component 1 is free to move intoand out of clamping-cutting device 102. As lever arms 6 move downward tothe closed position (FIG. 3), retractable arms 3F of clamping member 3radially close and apply substantially even circumferential pressure toopen ring ID of the ring component 1 to firmly close the ring ID andhold the ring component 1 in place as the housing 2 of theclamping-cutting surface 102 is advanced over the retractable arms 3F.In the clamped configuration, the ring component 1 and theclamping-cutting device 102 act as a single, integral componentcontrolled by the actuation of level arms 6. Downward progress ofcrushing-cutting component 102, a distance designated B, advanceshousing 2 over retractable arms 3F such that the clamping operation isfully activated or engaged. At the moment the housing 2 has beenadvanced the distance B and the crush has been completed, the blade hastraveled the same distance B and is positioned above the ring andcutting surface. It is not until the lever arm 6 has been furtheractuated and the housing 2 and blade 8 have been advanced further downclamping member 3 a distance designated A that the cutting edge 8A isbrought into contact with the cutting surface 1C of ring ID therebyincising the foreskin positioned between the cutting edge 8A and thecutting surface 1C. During further advancement of housing 2 over theretractable arms the crushing force of retractable arms 3F aremaintained by the inner diameter of the housing 2. The timing of thecrush and cut is controlled by distances A and B. These distances aresufficiently different to ensure that the clamping action occurs priorto the incision. And more importantly, that an incision can not possiblybe made without first activating and maintaining the clamping action.Downward progress A of crushing-cutting component 102 stops when thecutting edge 8A of blade 8 contacts the top or cutting surface 1C ofring ID of the ring component 1. The sequence of the crush and cut iscontrolled by the device itself when the operator actuates the leverarms downward fully in one single motion. As lever arms 6 are actuated,the present invention clamps the foreskin radially to create asubstantially symmetrical and even circumferential hemostasis at theaxial position and at the same time as the motion continues and onlyafter the crush has occurred, delivers the cutting edge of blade 8 tothe cutting surface 1C of the ring ID completing the incision slightlyabove where the clamping member 3 crushed the foreskin and achieved thehemostasis effect. The incision to the foreskin is made while theforeskin is within housing 2 and can be out of the direct line of sightof the operator if housing 2 is made of a non-transparent material orcolored.

Housing 2 is generally cylindrical, hollow, and vertically longitudinalhaving a top portion 2B and a bottom portion 2C. Housing 2 includes topportion 2B, bottom portion 2C, opposing slots 2D, through bore 2E, topopening 2F, bottom opening 2G, assembly hole 2H, and two pairs ofprojections 21. Bore 2E includes a sufficiently sized inner surface andlength to receive therein clamping member 3, blade holder 4, gear track5, and ring component 1.

Two lever arms 6 are pivotally joined to top portion 2B about a pivotalaxis. Each lever arm 6 has a predetermined length and width sufficientto sustain the forces of clamping and cutting. Semi-circular gears 6Aare adapted to the distal end 6B of each lever arm 6 and a handle at theother end. Lever arms 6 are positioned on opposite sides of top portion2B of housing 2 and positioned such that a portion of semi-circular gear6A extends through a slot 2D in housing 2 so as to engage gear track 5within housing 2. Each semi-circular gear 6A includes a plurality ofgear teeth 6C. Width of lever arms 6 are sized to fit between pair ofprojections 21 and are pivotally attached to projections 21 by aconventional joining device (not shown) such as bolt/nut or bushing orpressed fit pin connection. Each projection 21 may include hole 2J toreceive the conventional joining device. Each semi-circular gear 6A mayinclude a through bore 6D to receive the conventional joining meansthere through pivotally connecting each lever arm 6 and projection 21with one conventional joining means. Alternatively, two conventionaljoining means can be inserted through each projection 21 intosemi-circular gears 6A, either with or without a through bore, to formthe pivotal connection. Projections 21 act as a pivotal axis for leverarms 6 and allow lever arms 6 to rotate or pivot about an axis. Pivotalmovement of lever arms 6 causes rotation of semi-circular gears 6A toimpart reciprocating movement to gear track 5. Semi-circular gears 6Ahave a diameter that is sufficient to linearly move housing 2 up anddown over retractable arms 3F.

Bottom opening 2G of bottom portion 2C of housing 2 has an insidediameter that is made to accommodate the top portion of clamping member3. As housing 2 is advanced down over clamping member 3, the insidediameter of housing 2 causes retractable arms 3F of clamping member 3 toradially close, such that when housing 2 is advance completely overclamping member 3, retractable arms 3F are closed and in a position toengage open ring ID and exert a significant compressive force on groovedouter surface IF of open ring ID.

Gear track 5 includes a plurality of gear teeth 5 A evenly spaced alongthe length of gear track 5. Gear track 5 further includes through radialhole 5B for connecting clamping member 3 to gear track 5 (disclosed indetail below). Gear track 5 is initially positioned within top portion2B of housing 2 and is capable of axial movement within housing 2 ineither longitudinal direction. Gear teeth 5 A of gear track 5 cooperatewith gear teeth 6C of semi-circular gears 6A to translate gear track 5axially within bore 2E of housing 2. Gear track 5 has a verticalpassageway 5C extending through its axial center that is sized toreceive only the narrow portion of shaft IA of ring component 1. Byaccommodating only the narrow part of shaft IA, bottom face 5D contactsor rests on notch, ledge or shoulder IG of shaft IA, and thereforealigns the clamping-cutting device 102 with ring component 1 and openring ID (discussed in detail below). Shoulder IG can be formed by shaftIA having two sections with different diameters: an upper section IJhaving a diameter smaller than diameter of 5C and a lower section IAhaving a diameter larger than diameter of 5C. Gear track 5 is freelyrotatable about its axis and gear teeth 5A extend circumferentiallyaround gear track 5. The contact at any given time between gear teeth 6Cof semi-circular gear 6A and gear teeth 5A on gear track 5 is limited toa single tooth and preferably a single point contact.

Blade holder 4 includes circular blade 8 and blade support 4A. Circularblade 8 and blade support 4A are connected by conventional meansincluding, for example, snap fit, press or interference fit, cooperatingmale/female threaded members, screw, bolt, pin, weld, or adhesive. Bladesupport 4A includes longitudinal through bore 4B (disclosed in detailbelow). Blade support 4A may include retention hole 4C to connect bladeholder 4 to housing 2 with, for example pin 22. Further, blade holder 4has an outer diameter less then that of the inside diameter of clampingmember 3 such that blade holder 4 can move freely longitudinally withinclamping member 3. At the location of slot 3D in clamping member 3,blade holder 4 is affixed to housing 2 and moves simultaneously withhousing 2. Blade holder 4 and housing 2 are attached together and moveas one component. The attachment point occurs at the location of slot 3Dsuch that housing 2 and blade holder 4 can move independently ofclamping member 3.

Clamping member 3 is generally a hollow cylindrical member with lowerend 3A and upper end 3C. Clamping member 3 is freely moveable within thelower part of housing 2. The hollow center of clamping member 3 allowsfor the positioning and passing therethrough of blade holder 4. Clampingmember 3 includes a plurality of retractable arms 3F at lower end 3A.Upper end 3C is defined by two extensions 3B positioned on oppositesides of the cylinder at upper end 3C. Pair of extensions 3B are adaptedto form slot 3D. Slot 3D is sized to receive blade holder 4 and geartrack 5. Each extension 3B includes retention hole 3E for connectingclamping member 3 to gear track 5 with, for example, pin 23. Slot 3Dextends longitudinally along the cylinder and allows for fixation ofblade holder 4 to housing 2 (discussed in detail below) withoutinterfering with clamping member 3 ability to traverse within housing 2.Once clamping member 3 is fixedly attached to gear track 5, gear track 5drives housing 2 up and down over clamping member 3, thereby opening andclosing retractable arms 3F.

As discussed above, lower end 3A of clamping member 3 includes aplurality of circumferentially evenly spaced, downwardly facing,outwardly tapered, flexible retractable arms 3F. Retractable arms 3F canbe made of elastic material, such as plastic, metal, graphite, or otherpolymer, that retains its spring-like characteristics. The ends ofretractable arms 3F form an opening 3G adapted to engage grooved outersurface IF of open ring ID. When the present invention is in the openedor relaxed position, opening 3G is larger then the outer diameter ofopen ring ID. Retractable arms 3F extend outwardly in a tapered mannerallowing for an open position that allows for positioning of clampingmember 3 over the outside diameter of the upper section IJ of shaft IA.As housing 2 is advanced down over retractable arms 3F, the insidediameter of housing 2 engages the tapered edge of retractable arms 3Fand results in the closure of retractable arms 3F. When retractable arms3F are closed, the ends of retractable arms 3F define an opening 3G thatis substantially the same diameter as the outer diameter of open ring IDwhen gap IE of open ring ID is closed. Retractable arms 3F, when closed,cooperate with grooved outer surface IF of open ring ID to crush theforeskin for a hemostasis effect and hold open ring ID in a secure,fixed position prior to the delivery of the axial force of blade 8 tothe prepuce foreskin.

As discussed above, retractable arms 3F are fully extended or opened inthe unrestrained condition, thereby forming the largest opening diameter3 G possible. As retractable arms 3F are drawn axially into, forexample, housing 2, retractable arms 3F move radially inward, therebyreducing the diameter of opening 3G. Retractable arms 3F are adapted toengaged ring component 1, crush the foreskin, and restrain the movementof ring component 1. Each retractable arm 3F may include inward radialextension 3H, which is preferably curved to fit the contour of groovedouter surface IF, to further enhance the hemostasis effect. Fourretractable arms are illustrated, however, any number of arms areacceptable that achieve the desired results discussed in detail below.

One embodiment of the clamping-cutting device 102 can be assembled byaligning retention hole 3E of clamping member 3 with radial hole 5B ofgear track 5. A conventional means such as a screw, bolt, or press-fitpin 23 is inserted through retention hole 3E and radial hole 5B of geartrack 5, thereby connecting together clamping member 3 and gear track 5.Blade holder 4 is placed within the assembled clamping member 3/geartrack 5 and the entire assembly is positioned within through bore 2E ofhousing 2. Retention hole 4C of blade holder 4 is aligned with assemblyhole 2H of housing 2. A conventional means such as a screw, bolt, orpress-fit pin 22 is inserted through retention hole 4C of blade holder 4and assembly hole 2H of housing 2, thereby connecting together housing 2and blade holder 4. Each lever arm 6 is positioned between pair ofprojections 21. Semi-circular gears 6A are extended into housing 2Athrough slot 2D. Gear teeth 6C of semi-circular gears 6A are positionedto engage gears 5A of gear track 5. A conventional joining device isadapted to pivotally attach lever arm 6 to projection 21, therebycompleting the assembly of clamping-cutting device 102.

Now turning to FIG. 4, ring component 1 is generally a single piece ofmalleable, elastic material (such as plastic) with an open ring IDmounted orthogonally to shaft IA by curved member IH, which allowsmanipulation of open ring ID within the foreskin. Shaft IA includes aplurality of diameters to control the insertion of ring component 1 intoclamping-cutting device 102. A shaft diameter change can be delineatedby a notch or ledge or, as illustrated in FIG. 1, shoulder IG that actsas a stop of ring component 1 into clamping-cutting device 102. Openring ID includes a cutting surface 1C on its top surface being adaptedto act as a cutting surface when cutting edge 8 A of blade 8 is presseddown against foreskin interposed between cutting surface 1C and cuttingedge 8A. Open ring ID may also include grooved outer surface IF adaptedto engage with inward radial extension 3H of retractable arm 3F to holdring component in a stationary position relative to housing 2 during theclamping/cutting operation, such that the foreskin is trapped betweenthe grooved outer surface IF and the retractable arms 3F. Further,grooved outer surface IF will interact with inward radial extension 3Hto crush the foreskin against open ring ID and contemporaneously holdring component 1 in position while circular blade 8 is delivered to makethe incision in the foreskin. Open ring ID includes an opening or gap IElarge enough to allow the thickness of the foreskin to enter. The innerdiameter of the open ring ID is large enough to receive a predeterminedsized glans and shield the glans or head of the penis from being clampedand/or cut.

FIGS. 5, 6, 7, and 8 demonstrate the insertion of open ring ID into theneonatal foreskin 15. As discussed above, opening IE allows entry ofopen ring ID into foreskin 15. Foreskin 15 is held by an atraumaticforceps 13 while opening IE is positioned to enter foreskin 15. With apair of non-traumatic forceps, the foreskin is gently grasped andforeskin 15 is guided into the narrow gap IE of open ring ID. With ascrew-like motion of shaft IA of ring component 1, the open edge of openring ID is advanced in, down, and around the inner aspect of theforeskin. The opening or gap IE in open ring ID allows the open edge tobe advanced into the foreskin with a smooth, non traumatic fluidscrewing motion. Once open ring ID is fully inserted and resides justbeneath foreskin 15, it can be pushed down slowly toward the glans tofree any adhesions. Inside foreskin 15, opening or gap IE is closed bythe elastic nature of the foreskin. The closed open ring ID, inside theforeskin of the penis, residing just above the glans or tip of thepenis, is then used as the compressive surface for any number of clamps,such as inward radial extension 3H, and its top surface acts as acombination glans shield and or cut surface for blade 8 as it cuts theforeskin.

FIG. 9 illustrates the method of using the present invention to performa neonatal circumcision. Step A: Open ring ID of ring component 1 isinserted into the foreskin of the penis, as discussed above. Step B:Clamping-cutting device 102 is set in the open position with lever arms6 rotated up and retractable arms 3F extending fully through the bottomof housing 2. Step C: Clamping-cutting device 102 is inserted onto shaftIA of ring component 1. Downward movement of clamping-cutting device 102and housing 2 onto shaft IA is stopped when shoulder IG contacts bottomface 5D of gear track. Step D: Lever arms 6 are activated downward toadvance housing 2 downward over retractable arms 3F causing the clampingforce and delivering the circular blade to the foreskin. Morespecifically, semi-circular gears 6A of lever arms 6 engage with gearteeth 5A of gear track 5 of clamping-cutting device 102. Housing 2 movesdownwardly over retractable arms 3F causing retractable arms 3F toradially close on to and to exert lateral compressive force against theforeskin. Retractable arms 3F exert sufficient lateral compressive forcesuch that inward radial extensions 3H of retractable arms 3F forces theforeskin into grooved outer surface IF of open ring ID, thereby clampingthe foreskin without any trauma or deformation between the ringcomponent 1 and the clamping-cutting device 102. As housing 2 isadvanced even further over the open ring ID, blade 8 is delivered to thetop surface of open ring ID and creates the circular incision into theforeskin when open ring ID is within housing 2. Using the top surface 1Cof open ring ID as the cutting surface that is held in place by theclosed retractable arms 3F, blade 8 makes a single, clean,circumferential incision on top of the ring, removing the excessforeskin. The clamp is left in place for a period of time ensuringadequate crushing and hemostasis. Step E: Lever arms 6 are lifted upwardand retractable arms 3F release ring component 1, lifting housing 2 ofthe clamping-cutting device 102 and lifting blade 8 back up into housing2 and releasing open ring ID. Shaft IA with severed foreskin is removedfrom housing 2. All components of the present invention and byproductsof the operation are thrown away, thereby completing the circumcision.

FIGS. 10, 11, and 12 illustrate how the present invention eliminates thechance of mismatched parts. In FIG. 10, smaller ring component 16 isshown inside larger housing 17. The location of the shoulder 10 on theshaft of ring component 16 prevents shaft from being inserted all theway into the housing 17. With open ring extending below retractablearms, clamping-cutting surface apparatus 16 and housing 17 are notengaged and blade may not cut foreskin. Therefore, the use of a smallerring component 16 with larger housing 17 is prevented.

FIG. 11 illustrates a proper fit between ring component 18 and housing17. Ring component 18 is the appropriate size for the housing 17 and theretractable arms 9 are perfectly aligned with the open ring 14. Ringcomponent 18 and housing 17 engage and blade cuts foreskin.

FIG. 12 illustrates how a larger ring component 19 interacts with asmaller housing 17. In this case, it is the diameter of the shaft ofring component 19 that prevents the shaft from being inserted intohousing 17. On the shaft of ring component 19, the location of theshoulder and the diameter of the shaft make up two variables that areused together to completely eliminate the chance that a wrong size ringcomponent could be used with a wrong size housing. Colored coded ringsthat match the appropriate size housing can be used to help usersidentify appropriate parts and appropriate sizes.

FIGS. 13 and 14 illustrate an alternative embodiment of theclamping-cutting device of the present invention having a lever-lockingsystem to ensure more accurate deployment of lever arms 6. Lever arm 6is in the up or open position aligning slot 21 in the pivotal axialshaft of the lever arm 6 that would allow lever arm 6 to be slid intoposition on the shaft 1. Because of slot 21, lever arm 6, in theposition shown, can not be deployed. Lever arm 6 is jammed or blockedfrom rotating because of the shaft.

In FIG. 14, lever arm 6 has been moved down shaft 1 and is aligned withcurved notch 20 in shaft 1. Curved notch 20 allows lever arm 6 to rotateto the down or closed position. The location of curved notch 21 in shaft1 ensures that lever arms 6 can only be deployed when theclamping-cutting device 2 is in the precise location on shaft 1.Furthermore, once lever arm 6 is deployed, lever arm 6 can not move upor down on shaft 1 because it becomes locked in place as a result of thecurved notch 21.

FIGS. 15 and 16 illustrate yet another alternative embodiment of theclamping-cutting device of the present invention in the open and closedposition. This embodiment incorporates a means to generate a clickingsound when the lever arm has moved a sufficient distance to ensureclamping and cutting. Elastic projection 24 of semicircular gear 6Amakes contact with projection 25 of the clamping member 3. As thesemicircular gear 6A rotates, elastic projection 24 is held byprojection 25 until semicircular gear 6A rotates a sufficient amountthat elastic projection 24 snaps free thereby striking surface 26 of theclamping member and making a distinct click. The position of the elasticprojection 24 on the semicircular gear 6A is such that the clickingsound occurs when the lever arm 6 is in the fully closed or downposition. The clicking sound provides an audible signal to the operatorthat the lever arm has been appropriately deployed and that the crushingand cutting is complete.

FIGS. 15 and 16 also demonstrate a clamping-cutting device that has ahousing 2 that is fixed to clamping member 3. Once in position on ringcomponent 1, the housing 2 of the clamping-cutting device 102 does notmove. Activation of lever arm 6 and semicircular gears 6A causesrotation about an axis fixed to housing 2. Rotation of the semicirculargears 6A activates reciprocating movement of an internal cylindricalsleeve 27 that moves within housing 2 and can be advanced over theclamping member 3 to close retractable arms 3F. The internal sleeve 27is fixedly attached to blade holder 4 allowing advancement of the sleeve27 to deliver the blade holder 4 and the cutting surface to ring ID ofring component 1. FIG. 16 demonstrates sleeve 27 and blade holder 4 inthe up position, retracted into housing 2. FIG. 15 demonstrates sleeve27 and blade holder 4 in the down position, extending below housing 2,closing retractable arms 3F and delivering the cutting surface to thetop surface of the ring ID.

FIG. 16 also demonstrates a clamping-cutting device that utilizes justone lever arm and demonstrates how the lever-locking system can be used.As shown if FIG. 16, the shaft IA of the ring component 1 can only beinserted into the thru hole 2E of the housing 2 when the lever arm 6 isin the up position thereby aligning slot 21 vertically and allowingclearance for shaft IA to traverse through thru hole 2E. Once the ringcomponent 1 is inserted into thru hole 2E of housing 2, the notch 21prevents rotation of the lever arms 6. FIG. 15 demonstrates how rotationof the lever arms can only be initiated when slot 20 of the ringcomponent 1 is aligned with notch 21 allowing rotation of the lever armsand activation of the clamping-cutting device. At the precise locationwhere notch 21 is aligned with slot 20, the ring component 1 is inperfect alignment with the clamping-cutting device 102. It is only whensuch precise alignment occurs that the operator is able to activate theclamping-cutting device.

FIGS. 17 and 18 illustrate other alternative embodiments of theclamping-cutting device of the present invention wherein aclamping-cutting device utilizes a threaded screw to advance the housingover the retractable arms.

FIGS. 19 and 20 illustrate yet other alternative embodiments of theclamping-cutting device of the present invention that uses one lever armand a lining system.

The following disclosure of the present invention illustrates theself-adjusting pressure applicator adapted for use with a circumcisiontool. However, it is contemplated within the scope of the invention foruses on any tissue such as brain or neuron tissue or cardiac vessel, aswell as foreskin. Therefore, the invention should not be limited to usewith only a circumcision tool as disclosed.

One embodiment of the self-adjusting pressure applicator 110,illustrated in FIGS. 21A and 21B, includes ring component 112 andforeskin holder 114. FIGS. 21A and 21B illustrate ring component 112 andforeskin holder 114 in the disengaged and engaged positions,respectively. Ring component 112 is a single, one-piece, solid membermade from, for example, injection molding of a malleable, elasticmaterial (such as plastic) with an open ring 116 mounted orthogonally tolower shaft 118 by curved member 120, which allows manipulation of ring116 within the foreskin. Ring component 112 includes a position adjustor134 that delineates the lower shaft 118 from the upper shaft 136. Ring116 can include an opening or gap 130 large enough to allow thethickness of the foreskin to enter. Ring 116 can include an innerdiameter 132 large enough to receive a predetermined sized glans andshield the glans or head of the penis from being clamped and/or cut.Lower Shaft 118 (not shown) and/or upper shaft 136 (shown) can include aplurality of diameters 122A, 122B to control the insertion of ringcomponent 112 into a clamping-cutting device 200 (disclosed in PCTinternational application PCT/US2005/022404 and incorporated herein byreference). A shaft diameter change can be delineated by a notch orledge or, as illustrated in FIG. 21A, shoulder 124 that acts as a stopof ring component 112 into clamping-cutting device 200 (see FIG. 30).

Now turning to FIGS. 31A-D, ring 116 includes a holding/cutting surface126 on its top surface being adapted to act as a holding surface whenforeskin holder 114 is engaged and a cutting surface when cutting edge202 of blade 204 of clamping-cutting device 200 is pressed down againstforeskin 115 interposed between holding/cutting surface 126 and cuttingedge 202. Ring 116 may also include grooved outer surface 128 adapted toengage with inward radial extension or projection 206 of retractable arm208 to hold ring component 112 in a stationary position relative toclamping-cutting device 200 (See FIGS. 31A-B) during theclamping/cutting operation, such that the foreskin 115 is trappedbetween the grooved outer surface 128 and the radial extension 206 ofthe retractable arms 208 (See FIGS. 31A-B). Grooved outer surface 128will interact with inward radial extension 206 to crush the foreskinagainst grooved outer surface 128 and contemporaneously hold ringcomponent 112 in position while circular blade 204 is delivered to makethe incision in the foreskin.

Now returning to FIGS. 21A and 21B, one example of the self-adjustingpressure applicator 110 illustrates position adjustor 134 thatcooperates with malleable, spring-like opposing arms 138 of foreskinholder 114 to apply a hands-free self-adjusting constant pressure forceupon the foreskin disposed between lower surface 140 of foreskin holder114 (FIGS. 21A and 21B) and holding/cutting surface 126 of ringcomponent 112. Malleable arms 138 and position adjustor 134 act aspressure force generators. This arrangement provides for flexibility inpositioning the foreskin prior to cutting while maintaining apredetermined pressure force. One embodiment for the present inventionapplies a pressure force between 50 and 200 grams to the tissue whenengaged. Another embodiment applies a pressure force of about 181 gramsof force to the tissue when engaged. The pressure force is exerted alonga common centerline of ring component 112 and foreskin holder 114.

One embodiment of the present invention is engaged only long enough toinsert the self-adjusting pressure applicator 110 into the clamp,activate the clamp or otherwise cut the foreskin, thereby removing theretained foreskin from the patient. For example, the self-adjustingpressure applicator 110 can be engaged ranging from about 30 seconds toabout one minute, the foreskin can be positioned between the twocomponents, the clamp applied, and the retained foreskin crushed andexcised. The agility, flexibility, and simplicity of the self-adjustingpressure applicator 110 allows for repositioning of the foreskin toassure substantially full or entire circumferential retention of theforeskin or tissue. Such minor adjustments can be made with greatprecision within a short period of time and with no tissue damage.Providing full circumferential retention of the foreskin or tissue alongthe crushing and cutting surface results in an improvement of thesurgical removal of the foreskin or tissue without the use of barbs,pins, clips, or hemostats.

Another embodiment of the self-adjusting pressure applicator 110 appliesthe pressure force indefinitely to the tissue being retained allowingfor prolonged surgical manipulation of that tissue without causingpermanent injury.

One embodiment of position adjustor 134 is generally a circular body,having a tapered surface, and can be, for example, in the form of twounequal half spheres (similar to football halves) that create a shoulderor lip 142 when joined together. An upper half sphere 144 can have adiameter at the joining interface 148 larger then the mating diameter oflower half sphere 146. Spheres 144, 146 each have a tapered surface tofacilitate the upward and downward movement of malleable arms 138 on thespheres 144, 146. The shoulder 142 formed at interface 148 acts as amalleable arm stop to inhibit the upward progress of malleable arms 138as the foreskin is pulled upward to position it for crushing andcutting. The malleable arms 138 must be spread open to fit over shoulder142 and into the disengaged position. The concave configuration ofmalleable arms 138 can be sized and shaped similar to spheres 144, 146for containment of the foreskin holder 114 while in the disengagedposition (FIG. 21A) and for spring-back properties while in the engagedposition (FIG. 21B). The tapered surface of lower sphere 146 can besized and shaped to provide the desired predetermined pressure forcetaking into consideration the spring-back force of malleable arms 138.Malleable arms 138 must always be in contact with lower sphere 146 tomaintain a constant predetermined pressure on to the foreskin whenforeskin is disposed between lower surface 140 of foreskin holder 114and holding/cutting surface 126 of the ring component 112.

In furtherance of the description to hold foreskin in a preciselocation, when the foreskin holder 114 is positioned in the down orengaged position, malleable arms 138 of the foreskin holder 114 interactwith the lower tapered surface 146 of position adjustor 134 forming aspring-like mechanism to create a force in the direction towardsholding/cutting surface 116 and away from position adjustor 134. Thespring-like mechanism exerts a force that holds foreskin holder 114 inplace along the holding/cutting surface 126 of ring component 112. Thepressure force in turn holds the foreskin in place that is positionedbetween the holding/cutting surface 126 and the foreskin holder ringportion 156. Ring portion 156 at the base of the foreskin holder 114applies a 360° circumferential force to the holding/cutting surface 126to achieve a substantially constant circumferential pressure or holdingforce. Shoulder 142 of the position adjustor 134 along interface 148acts as a latch allowing for malleable arms 138 to move down lower shaft118, but prevents inadvertent movement of foreskin holder 114 back upinto the disengaged position. Shoulder 142 ensures that malleable arms138 and lower tapered surface 146 maintain in an axial position thatgenerates the spring-like force holding the foreskin holder 114 in placerelative to holding/cutting surface 126 of ring component 112. Ringportion 156 of foreskin holder 114 is preferably supported by twosupport arms 158 (discussed in detail below) that allow for easyvisibility and access to the foreskin that becomes retained within thecavity 161 of foreskin holder 114.

Now turning to FIG. 22 for a complete discussion of foreskin holder 114.One example of the foreskin holder 114 is a single, one-piece, injectedmolded, solid member constructed of malleable, elastic material (such asplastic). As mentioned above, foreskin holder 114 includes a ringportion 156, a pair of support arms 158, a C-shaped sleeve 160, and apair of malleable arms 138. Ring portion 156 is configured to alignjuxtaposition to the holding/cutting surface 126 of ring 116 (see FIG.21A) of the ring component 112. Ring portion 156 is generally circularwith an inner diameter 132, outer diameter 172, a bottom surface 140,and a top surface 164. Bottom surface 140 is a pressure surface thatcontacts and applies pressure to the foreskin disposed between theholding/cutting surface 126 of the ring component 112.

As discussed above, malleable arms 138 will exert a downward forcecaused by its interaction with a position adjustor 134 on the modifiedring component 112. The spring coefficient of the malleable arms 138 canbe derived by well known methods to accommodate the desired pressureforce. The desired pressure force can be determined by knowing, amongother characteristics, thickness of tissues including but not limited toforeskin, brain or neuron tissue, or cardiac vessel. The downward forceis translated through C-shaped sleeve 160 to support arms 158. Supportsarms 158 applies the translated force to ring portion 156 atinterconnect points 166. The force will be substantially evenlydistributed along lower surface 140 when lower surface 140 is in contactwith foreskin disposed between lower surface 140 and holding/cuttingsurface 126 of the ring component 112. The force or contact pressuredistribution along to lower surface 140 is a function of width W ofsupport arms 158 and the rigidity of ring portion 156. For example, thewider the support arms 158, the more ring portion surface area in thedirect load path of the translated force. Ring portion 156 would bendless when the ring portion 156 is more rigid. Bending of ring portion156 could cause a reduction of the contact pressure along lower surface140 as a function of circumferential distance from the interconnectpoints 166.

Though a pair of independently deflectable malleable arms have been usedto illustrate a spring-like mechanism to apply a pressure force, itshould be appreciated that there are many suitable combinations of arm(deflectable or rigid) or spring-like mechanisms incorporated into thebody of the position adjustor 134 that will achieve the desired results.The invention should not be limited to only the embodiments disclosed inthis application.

Now turning in FIGS. 23A-C, one embodiment of a support arm 158 caninclude one or more sections. Shown as an example is support arm 158having two sections 158A, 158B. Two support arms 158 provides for easiervisibility and access to the foreskin that becomes retained within theforeskin holder 114. Section 158A is attached at one of its ends 158C toeither top surface 164 or to the inner diameter 133 (FIG. 23C) or to theouter diameter 172. One embodiment of Section 158A can be orientedorthogonal to ring portion 156. However any angle α (FIG. 23B) thatapplies evenly distributed forces along lower surface 140 of ringportion 156 is acceptable. Section 158B is attached at a predeterminedangle Ø at one of its ends 158E to the other end 158D of section 158A,and at its other end 158F to C-shaped sleeve 160 at its end 160A at apredetermined angle β. The angular relationships between sections 158Aand 158B and C-shaped sleeve 160 create an inward taper of support arms158. The predetermined angles α, Ø, and β, and therefore the support armtaper, can be variable to accommodate the independent optimization ofring portion 156 and C-shaped sleeve 160, and/or to optimize the contactpressure along lower surface 140. In the case where Ø is 180°, therewill only be one section 158. Though the preferred number of supportarms is two, any number of support arms is acceptable and within thecontemplation of the invention.

Continuing with the embodiment illustrated in FIG. 23B, each malleablearm 138 is attached at one of its ends 138A to end 160B of C-shapedsleeve 160 and its other end 138B is free to independently flex ordeflect (X) and form a gap (Y) at rest. Free ends 138B can deflect topredetermined distance X under predetermined load or force conditions(discussed in detail below). The flexed or deflected malleable arms actlike a spring storing energy to produce a spring back force, which is afunction of the deflection distance X. The larger the deflectiondistance X, the more spring-back force will be created. Since the springback force is also a function of the materials property, for example themodulus of elasticity, material selection is also important indetermining the desired spring back force. It will become apparent laterin this application that the spring back force will act upon a positionadjustor 134 of ring component 112 to result in a downward movement offoreskin holder 114 that applies the pressure force to the foreskindisposed between lower surface 140 and holding/cutting surface 126 ofring component 112. Malleable arms 138 can be of any configuration thatresults in the desired spring back force working in conjunction withposition adjustor 134 of ring component 112. For example, malleable arms138 can have a concave surface 154 and be opposingly oriented to eachother. As discussed above, the type of materials, dimensions (thickness,width, length) of malleable arms 138, and/or shape of malleable arms 138(concave or convex) are derivable from the desired pressure force to beapplied to a target tissue, such as foreskin, brain or neuro tissue, orcardiac vessel.

Now turning to FIG. 23C, C-shaped sleeve 160 in generally cylindrical inshape and hollow having an outer diameter 160C, an inner diameter 160D,and two circumferential ends 160E, which form slot 160F with gap 160G.Gap 160G is less than inner diameter 160D of C-shaped sleeve 160 andless than the outer diameter 176 of lower shaft 118 of ring component112 (FIG. 21A). C-shape sleeve 160 has sufficient elastic propertiessuch that gap 160G will open as lower shaft 118 is inserted through slot160F and gap 160G will close or return to its original gap distance 160Gafter insertion of lower shaft 118 into slot 160F. Once lower shaft 118is inserted through slot 160F, it is trapped or entrained withinC-shaped sleeve 160 and only permitted to move along in a longitudinalpath within C-shape sleeve 160 because outer diameter 176 is smallerthan inner diameter 160D to allow for lower shaft 118 to movelongitudinally within inner diameter 160D. Ends 160E can be rounded tofacilitate easier insertion of lower shaft 118 through slot 160F. FIGS.24A-C illustrate foreskin holder 114 (female component) being positionedon ring component 112 (male component) (FIG. 24A), alignment of slot160F of foreskin holder 114 with lower shaft 118 of ring component 112prior to insertion (FIG. 24B), and foreskin holder 114 slidablyconnected with ring component 112 after insertion of lower shaft 118through slot 160F (FIG. 24C).

One embodiment of outer diameter 160C can include finger grips 160H tofacilitate a better grip for raising and lowering foreskin holder 114relative to ring component 112. Finger grips 160H can be one or moreprojections. As shown in FIGS. 23A and 23B, three projections 160H arecircumferentially oriented parallel to each other along outer diameter160C. Any cluster or grouping of projections are acceptable as well asany surface treatment that creates a frictional condition between theuser's fingers and outer diameter 160C.

FIGS. 25-28 demonstrate an example of the insertion of ring 116 into theforeskin 115. As discussed above, gap 130 allows entry of ring 116 intoforeskin 115. Foreskin 115 is held by an atraumatic forceps 113 whilegap 130 is positioned to enter foreskin 115. With a pair ofnon-traumatic forceps, the foreskin is gently grasped and foreskin 115is guided into the gap 130 of ring 116. With a screw-like motion oflower shaft 118 of ring component 112, the ring 116 is advanced in,down, and around the inner aspect of the foreskin 115. The gap 130 inring 116 allows the ring 116 to be advanced into the foreskin with asmooth, non traumatic fluid screwing motion. Once ring 116 is fullyinserted and resides just beneath foreskin 115, it can be pushed downslowly toward the glans to free any adhesions but to be surrounded byforeskin 115. Inside foreskin 115, gap 130 is closed by the elasticnature of the foreskin 115 attempting to return to its state after beingstretched during the insertion of ring 116. The closed ring 116, insidethe foreskin of the penis, residing just above the glans or tip of thepenis, is then used as the compressive surface for any number of clamps,such as inward radial extension 206 (tongue) and mating recess 207(groove) (FIG. 31A), and its top surface 126 acts as a combination glansshield, cutting surface for blade 204 as it cuts the foreskin, andforeskin holder when cooperating with foreskin holder 114.

FIGS. 29A-C illustrate the operation of foreskin holder 114 afterforeskin is positioned on the ring 116 of ring component 112 (hiddenbeneath foreskin 115). The operator pinches or grips finger grips 160Hof foreskin holder 114 and pushes foreskin holder 114 down towardsholding/cutting surface 126 (hidden beneath foreskin 115) (FIG. 29A).The dashed line represents the desired circular foreskin cuttingcircumference. Malleable arms 138 automatically open as malleable arms138 move down upper sphere 144 and then automatically close as malleablearms 138 transition to move down lower sphere 146. The operator usesforceps 113 to grab the foreskin 115 for initial positioning for asubstantially circular cut, shown as a dashed line (FIG. 29B). Afterinitial positioning, the operator pulls the foreskin 115 substantiallyupwards (FIG. 29C). Foreskin holder 114 may advance upward on to lowersphere 146. As foreskin holder 114 advances upward the spring back forceof malleable arms 138 increases and the downward pressure increases tocounter the upward pull on the foreskin and to maintain a substantiallyconstant circumferential pressure force onto the foreskin. Repositioningof the forceps may be necessary to assure the foreskin is evenlydistributed around holding/cutting surface 126 of ring component 112(hidden beneath foreskin 115) for a substantially circular cut (dashedline).

FIG. 30 illustrates one embodiment of the self-adjusting pressureapplicator 110 adapted for use with a circumcision clamping-cuttingdevice 200 (disclosed in PCT international application PCT/US2005/022404and incorporated herein by reference) adapted to cooperate with eachother. Step A: Ring 116 (hidden beneath foreskin) of ring component 112is inserted into the foreskin 115 of the penis, as discussed above. StepB: Clamping-cutting device 200 is set in the open position with leverarm 212 rotated up and retractable arms 208 extending fully through thebottom of housing 210 and sleeve 214. Step C: Clamping-cutting device200 is inserted onto upper shaft 136 of ring component 112. Downwardmovement of clamping-cutting device 200 and housing 210 onto upper shaft136 is stopped when shoulder 124 contacts bottom face of an internalthru hole (not shown). Step D: Lever arm 212 is activated downward toadvance sleeve 214 downward over retractable arms 208 causing theclamping force and delivering the internal circular blade 204 (FIG. 31A)to the foreskin 115. Sleeve 214 moves downwardly over retractable arms208 causing retractable arms 208 to radially close on to and to exertlateral compressive force against the foreskin 115. Turning to FIGS. 30and 31A and B, retractable arms 208 exert sufficient lateral compressiveforce or clamping such that inward radial extensions 206 (FIG. 31A) ofretractable arms 208 forces the foreskin 115 into grooved outer surface128 of ring 116, thereby clamping the foreskin 115. As sleeve 214 isadvanced even further over the ring 116, blade 204 is delivered to thetop surface 164 of ring 116 and creates the circular incision into theforeskin 115 when ring 116 is positioned within clamping-cutting device200 (FIG. 31B). Using the top surface 164 of ring 116 as the cuttingsurface that is held in place by the closed retractable arms 208, blade204 makes a single, clean, circumferential incision on top surface 164of ring 116, removing the excess foreskin 115. The clamp is left inplace for a period of time ensuring adequate crushing and hemostasis.Step E (FIG. 30): Lever arm 212 is lifted upward and retractable arms208 release ring component 112, lifting sleeve 214 of theclamping-cutting device 200 and lifting blade 204 back up into housing210 and releasing ring 116. Ring component 112 with severed foreskin ispermanently locked within housing (not shown) 210 to prevent inadvertentreuse of any of the components of the device. All components andbyproducts of the operation are thrown away, thereby completing thecircumcision.

FIGS. 31C and 31D show a bottom view of the clamping arms 208 withradial extensions 206 and corresponding recesses 207 in the open,neutral, pre-clamping position and the closed, clamping position, whereradial extensions 206 are substantially retained in recesses 207,respectively.

FIG. 32A illustrates the self-adjusting pressure applicator 110 and aconventional type clamp 300, which includes plate 302, nut 304, yolk306, and bell/stud 308, adapted to cooperate with each other.

FIG. 32B illustrates the self-adjusting pressure applicator 110 and aconventional type bell 400 adapted to cooperate with each other.

Anther embodiment of the present invention includes a ring component 500having a shaft 501 with a ring 502 (closed ring shown in FIGS. 33A-B oropen ring shown in FIG. 5) at a proximal end 503 and a tip 505 at adistal end 508, wherein the ring 502 comprises a radially orientedclamping surface 507 with a circumferential groove 509 and anaxially-oriented cutting surface 510. The ring 502 includes a lowprofile sufficiently sized to fit within a stretched foreskin (discussedin detail below) and the location of the single support 504. Thesefeatures allow for easier insertion without making a dorsal slit. FIG.34 demonstrates an example of the insertion of ring 502 into theforeskin 115.

Step 1: Foreskin 115 is held by an atraumatic forceps 113 while thedistal end 508 of ring component 500 is positioned through an opening117 in the foreskin 115 to clear the adhesions separating foreskin 115from the glans (not shown).

Step 2: A second pair of non-traumatic forceps 113A is inserted into theopening 117 of the foreskin 115 and the foreskin 115 is gently stretchedto open the opening 117.

Step 3: Ring 502 (step 3) is inserted into the opening 117.

Step 4: The foreskin 115 is gently grasped by the atraumatic forceps 113and the ring 502 is advanced in, down, and around the inner aspect ofthe foreskin 115. Once the ring 502 is fully inserted and resides justbeneath foreskin 115, it can be pushed down slowly toward the glans tofree any remaining adhesions. The ring 502, inside the foreskin of thepenis, residing just above the glans or tip of the penis, is then usedas the compressive surface for any number of clamps, such as inwardradial extension 206 including a tongue 206A and mating recess or groove207 (FIG. 31C), and its axially-oriented cutting surface 510 (FIG. 33A)acts as a combination glans shield, cutting surface for blade 204 as itcuts the foreskin 115.

Step 5: When foreskin holder 114 is used, then foreskin holder 114 isadvanced downward toward the glans and axially-oriented cutting surface510.

Step 6: Once foreskin holder 114 is in place securing foreskin 115disposed between lower surface 140 of foreskin holder 114 (FIGS. 21A and21B) and axially-oriented cutting surface 510 of ring 502, excessforeskin 115 is pulled upward to assure the cut is clean andsymmetrical.

As discussed above, each inward radial extension or projection 206 ofthe plurality of longitudinal clamping arms 208 comprise a tongue 206Aand a groove 207 such that the tongue 206A of the inward radialextension or projection 206 is received within the groove 207 of anadjacent inward radial projection 206 to form a circumferentiallyoverlapping configuration therewith and no radial-through gaptherebetween when the plurality of longitudinal clamping arms 208 are ina pre-clamp position to prevent foreskin migrating between the inwardradial extension or projections 206 during a clamping operation andpinching the foreskin.

FIGS. 35A-B illustrate an extension 520 at one end 523 of housing 2 toprotect the surrounding tissue, such as scrotum, when housing 2 isadvanced toward the penis during the crushing and cutting action.Extension 520 can include a base 522 attached to housing 2 with one ormore longitudinal supports 524. Base 520 can be circular (as shown) orany suitable geometry, such as semi-circular (not shown), to willprevent surrounding tissue from being damaged during crushing andcutting action. Outer surface 523A contacts body tissue around the penisto cause the stretching of the penis as the clamp mechanism is actuatedand the penis is drawn and guided through a bore 525 of the extension520 toward the housing 2 to ensure the penis is extended a predetermineddistance. The length L of the longitudinal supports 524 can beapproximately the length of the penis, such as 1 cm. Base 520 can be acontinuous surface (as shown) or can be discontinuous withintermittently spaced pads (not shown) having sufficient length andwidth such that the patient is not pierced or put in significantdiscomfort. The longitudinal supports 524 and base 520 form spaces 526providing a viewing area for the user to observe the activity into bore525.

FIG. 36 illustrates one embodiment of a visual indicator 528 thatprovides the user with an indication that ring component 500 is inposition for actuation of the lever arm 212 (FIG. 30). Visual indication528 can be a notch 530 with or without a color marking for ease ofdetection.

FIGS. 37A-B illustrate lever arm 212 prior to actuation and after fullactuation, respectively. Lever arm 212 can include a hook 532 having aconfiguration that interfaces with latch 532 attached to housing 2 toretain lever arm 212 in an engage position to assure adequate crushingand hemostasis. Due to the resistance force of the clamp arms 208 andblade 204, lever arm 212 will rotationally spring back from a maximumactuation position to a position beyond latch 534 towards the disengageposition. Latch 532 will mate with hook 532 to retain lever arm 212 in apredetermined position for period determined by the user.

FIGS. 39A-G illustrate an integral radial clamping and an axial cuttingdevice 499 comprising a two-piece housing 2, a core section 537, a leverarm 560, a pair of safety latch mechanisms 535A, 535B, and an actuationmechanism 521. The two-piece housing 2 forming a bore 539 having an openend 511 at a proximal end 541 and a closed end 513 having a hole 515 ata distal end 517 when the two-piece housing is assembled, wherein thehole 515 includes a diameter 519 larger than a diameter Di of the tip508 of the shaft 501. Core section 537 is encased within the bore 539 ofthe two-piece housing 2. Core section 537 having an axially orientedblade 544 disposed at a proximal end 541 and a lever arm pivot point 543at a distal end 545. Lever arm 560, which includes an engagement tooth556, is pivotally attached to the lever arm pivot point 543 of the coresection 537. A pair of safety latch mechanisms 353A, 535B are pivotallyattached to the core section 537, wherein the pair of safety latchmechanisms 353A, 535B form an initial gap 527 between inward orientedtabs 560A, 560B prior to actuation of the device. The actuationmechanism 521 is disposed within the bore 539 of the two-piece housing 2(discussed in detail below).

The actuation mechanism 521 includes a plurality of longitudinalretractable clamping or finger arms 542 at a proximal end 541 of theactuation mechanism 521 having inward radial projections or extensions529, wherein at least a portion 531 of the plurality of longitudinalretractable clamping or finger arms 542 are disposed outside the bore539 of the housing 2 forming a gap 533 between the inward radialprojections that is greater than a diameter 585 of the circumferentialgroove 509 of the radially oriented clamping surface 507 of the ringcomponent 550. Though four arms 542 are illustrated in this patentapplication, the invention is not to be limited to any particular numberof arms 542. Actuation mechanism 521 further includes a lever armengagement gear tooth 558 at a distal end 587 of the actuation mechanism521 to engage the engagement tooth 556 of the lever arm 560 when thelever arm 560 is actuated with the proper ring component 550 insertedtherein.

Once the ring 502 is inserted into the foreskin 115, as shown in FIG. 34and discussed above, then radial clamping and axial cutting can beperformed following the below steps:

Step 1: Inserting and advancing an end 508 of the ring component 550into an open end 511 of the integral radial clamping and an axialcutting device 499 until a visual or an audible indicator signals tostop advancing. A lock mechanism restraining relative movement of theradial clamping device and the axial cutting device is automaticallyreleased while the ring component is advanced into the integral radialclamping and the axial cutting device 499.

Step 2: Actuating the integral radial clamping and the axial cuttingdevice 499.

Step 3A: Decouple the radial clamping device from the axial cuttingdevice when a mis-matched ring component is inserted into the integralradial clamping device and the axial cutting device.

Step 3B: Radially clamping the foreskin against a circumference of thering and contemporaneously axially cutting the foreskin against the ringwith a single actuation motion by the lever arm 560 when a matched ringcomponent is inserted into the integral radial clamping device and theaxial cutting device.

Step 4: De-clamping the foreskin after the step of axially cutting.

FIGS. 39A-G further illustrate embodiments of the present invention thatinclude a slip gear 556 and safety latch mechanism 535A, 535B thatensure the present invention can only be used with the correctly sizedring component 550 and only when ring component 550 is correctlyinserted into housing 2 and locked in place. Safety latch mechanism535A, 535B are pivotally mounted to core section 537.

One embodiment of the present invention to prevent use of the wrong thering component 550 includes complementary limiting features on ringcomponent 550 and in core section 537. Ring component 550 comprises afirst limiting section 569 of the shaft 553 having a first diameter 567and a first section length 589, and a second limiting section 579 of theshaft 553 with a second diameter 591 greater than the first diameter 567and a second section length 583. The core section 537 comprises a ringcomponent limiting section 547 having a first section 549 with a borediameter 555 greater than a first diameter 567 of the first limitingsection 569 of the shaft 553 to receive the shaft 553 of the ringcomponent 550 there-through and a first section depth 571 (FIG. 39B),and a second section 573 with a bore diameter 575 greater than thesecond diameter 577 of the second limiting section 579 of the shaft 553and a second section depth 581, wherein the second section depth 581 ofthe second limiting section 579 of the core section 537 is substantiallyequal to the second section length 583 of the second limiting section579 of the ring component 550. The core section limiting sections 547and ring component shaft limiting sections 569, 579 may include tapers579T, 598T.

FIG. 41 illustrates examples of three embodiments of the diameters D1,D2, D3 of the first limiting section 569 of the shaft 553 and coresection first section 549 and the diameters D3, D4, D5 of the secondlimiting section 579 of the shaft 553 and core section second section573. The diameters D1, D2, D3 can be matched with any of the diametersD3, D4, D5 to make up to nine combinations of matched shafts 553 andcore sections 537.

FIGS. 42A-C illustrate a set of three clamps with different coresections and two rings with different limiting sections. FIG. 42Aillustrates Clamp I with a core section first section diameter of D andcore section second section A, Clamp II with a core section firstsection diameter of E and core section second section B, and Clamp IIIwith a core section first section diameter of F and core section secondsection C. FIG. 42C illustrates Ring I having a first limiting sectiondiameter of D and a second limiting section diameter of A. FIG. 42Billustrates Ring II having a first limiting section diameter of E and asecond limiting section diameter of B.

With regards to Clamp I and Ring I, first limiting section diameter D ofRing I is equal to core section first section diameter D and secondlimiting section diameter A of Ring I is equal to core section secondsection diameter A, so clamp I is a match with Ring I.

With regards to Clamp II and Ring I, first limiting section diameter Dof Ring I is greater than core section first section diameter E, soclamp II is not a match with Ring I notwithstanding second limitingsection diameter A of Ring I is a fit with core section second sectiondiameter B of Clamp II since diameter A is less than diameter B.

With regards to Clamp III and Ring I, first limiting section diameter Dof Ring I is greater than core section first section diameter F, soclamp III is not a match with Ring I notwithstanding second limitingsection diameter A of Ring I is a fit with core section second sectiondiameter C of Clamp III since diameter A is less than diameter C.

With regards to Clamp I and Ring II, second limiting section diameter Bof Ring II is greater than core section second section diameter A, soclamp I is not a match with Ring II notwithstanding first limitingsection diameter E of Ring II is a fit with core section first sectiondiameter D of Clamp I since diameter A is less than diameter B.

With regards to Clamp II and Ring II, first limiting section diameter Eof Ring II is equal to core section first section diameter E and secondlimiting section diameter B of Ring II is equal to core section secondsection diameter B, so clamp II is a match with Ring II.

With regards to Clamp III and Ring II, first limiting section diameter Eof Ring II is greater than core section first section diameter F, soclamp III is not a match with Ring II notwithstanding second limitingsection diameter B of Ring II is a fit with core section second sectiondiameter C of Clamp III since diameter B is less than diameter C.

As shown in FIG. 39A, safety latch mechanism 535A can include safetylatch 536 that can be retained in a hole or aperture 538 of clamp slidetube 540 to couple the clamp slide tube 540 with a core section 537 toprevent clamp slide tube 540 from moving up and down, thereby forming anintegral radial clamping device and an axial cutting device. As ringcomponent 550 is inserted into housing 2, large diameter mid-section 552of ring component 550 causes safety latch 536 to pivot about pivot point554 releasing clamp slide tube 540 (FIG. 39B). If the ring component 550is not inserted properly, then safety latch mechanism 535A will notallow the clamp slide tube 540 to advance within housing 2. Oneembodiment of a large diameter mid-section 552 can be defined by atapered section 551 ranging in diameter from an initial diameter Di ofshaft 553 of ring component 550 to a maximum Dx along tapered section551, which can be diameter De of tapered section end 564 (as shown inFIGS. 39A-E) or any other acceptable diametrical location depending onthe configuration of tapered section 551. Safety latch mechanism 535B,having pivot point 554B, can include inward oriented tab 560 thattravels along the outer surface 562 of ring component 550. As inwardoriented tab 560 travels along surface 561 of tapered section 551 oflarge diameter mid-section 552, safety latch mechanism 535B elasticallybends or deflects outward, pivots and springs back to make a clickingsound as inward oriented tab 560 passes tapered section end 564 oftapered section 551 of large diameter mid-section 552. The audible soundcan be made by inward oriented tab 560 contacting shaft diameter Dc(where Dc is less than De as shown in FIG. 39B) or by a contact point557 along inner surface 559 of safety latch mechanism 535B contacting acontact point along surface 561 (for example De) or both. Further, ringcomponent 550 is now retained by housing 2 once inward oriented tab 560passes tapered section end 564 of tapered section 551 of large diametermid-section 552.

As an illustration of a mis-matched ring component and clamp, oneembodiment includes a ring component with a tapered section 551 having afirst diameter Di and a second diameter Dx smaller than the initial gap527 between inward oriented tabs 560A, 560B prior to actuation of thedevice. The tapered section 551 passes through gap 527 withoutcontacting an end 560A. Therefore, safety latch mechanism 535A does notpivot to release the safety latch 536A from hole or aperture 538 on aninner surface 593 of the actuation mechanism 521 and decouple actuationmechanism 521 from core section 537 to activate the clamping-cuttingoperation. The operable tapered section 551 must have a first diameterDi smaller than the initial gap 527 and a second diameter Dx greaterthan the initial gap 527 such that safety latch mechanism 535A pivots torelease the safety latch 536A from hole or aperture 538.

Another locking mechanism is shown engaged in FIG. 39B. Safety latchmechanism 535A, 535B can either or both include inwardly orientedextensions 563A, 563B that pivotally rotate or spring into groove 565 ofring component 550 as ring component 550 advances into housing 2 toretain ring component 550 from further insertion into housing 2 orretraction from housing 2. As shown, safety latch mechanism 535A isslight shorter than safety latch mechanism 535B such that inwardoriented tab 560A rests on tapered section end 564 to induce sufficienttorque on to safety latch mechanism 535A causing safety latch mechanism535A to pivot and position inwardly oriented extension 563A into groove565. Inwardly oriented extension 563A can assert a sustained force ontoto groove 565 or be free to pivot about pivot point 554 but only to theextent not to exceed the depth D of groove 565. Depth D is defined ashalf the difference of the shaft diameter Di to groove diameter Dg(Depth groove=(Di−Dg)/2). One embodiment of safety latch mechanism 535Bis under constant bending load asserting a sustained force onto groove565 to assure that inward oriented tab 560A springs back to contact ringcomponent 550 to produce an audible sound.

Alternative configurations of safety latch mechanism 535A, 535B arecontemplated that either safety latch mechanism can be under a constantload, intermittent load, or no load condition and still perform thedesired functions of the present invention. For example, one embodiment(not shown) can include only safety latch mechanism 535A that retainsring component 550 and makes an audible sound when inwardly orientedextension 563A contacts groove 565. Another embodiment can includesafety latch mechanism 535A without inwardly oriented tab 563A (notshown) and safety latch mechanism 535B with inwardly oriented extension563B and inward oriented tab 560A as shown in FIGS. 39A-F. Yet anotherembodiment (not shown) can include safety latch mechanism 535A withoutinwardly oriented tab 563A and safety latch mechanism 535B with inwardlyoriented extension 563B and inward oriented tab 560B both sized andspaced such that inwardly oriented extension 563B produces the audiblesound when it contacts groove 565.

As shown in FIG. 39B-D, when clamp slide tube 540 advances downward,finger arms 542 close to clamp foreskin 546 and blade 544 is deliveredto top surface 548 of ring component 550. Engagement gear 556 interactswith gear rack 558 to advance clamp slide tube 540 towards top surface548 when ring component 550 is installed properly. Only a small force isrequired to initiate the two gears and move clamp slide tube 540downward by actuation of lever arm 560. Once the next set of gears areengaged, the device can exert the large force required to crush and cutthe foreskin 546.

However, when ring component 550 is installed improperly or notinstalled at all, slip gear tooth 556A will contact slip gear tooth 587of the actuation mechanism 521 and elastically deflect or bend at apredetermined force and slip passed slip gear tooth 587, therebydisabling the lever arm 560 to protect the entire device from damagesince clamp slide tube 540 is restrained from moving because safetylatch 536 is retained in hole or aperture 538 of clamp slide tube 540.If slip gear 556A slips, nothing is broken and the device can still beused. Once the user recognizes slip gear 556A has slipped, the user canthen lift lever arm 560 back to disengaged position and put in a correctring component 550 to successfully use the device.

FIG. 39E illustrates a successful application of the present inventionwhere the prepuce 562 stays with the device and is discarded after asingle use.

FIGS. 39F-G illustrate the adjacent orientation of lever arm 560 withrespect to slip gear 556. It can be seen that when slip gear 556 slips,lever arm 560 will move independent of gear rack 558 since slip gear 556and gear rack 558 are co-planar, whereas lever arm 560 is not in thesame plane as slip gear 556 and gear rack 558.

FIG. 40 is an exploded view of the present invention illustrated inFIGS. 39A-G.

Further embodiments of the above disclosed components are disclosed inU.S. patent application Ser. No. 11/571,120 filed on Dec. 21, 2006,“Atraumatic Circumcision Device and Method to Use”, by David R.Tomlinson, which is a U.S. national phase entry of Patent CooperationTreaty international application serial number PCT/US2005/022404 filedon Jun. 23, 2005, “Atraumatic Circumcision Device and Method to Use”, byDavid R. Tomlinson, which claims priority to U.S. provisionalapplication Ser. No. 60/583,259 filed on Jun. 25, 2004, “AtraumaticCircumcision Ring and Method”, by David R. Tomlinson, and U.S. patentapplication Ser. No. 11/768,808 filed on Jun. 26, 2007, “Self-AdjustingPressure Applicator”, by David R. Tomlinson, which claims priority toU.S. provisional application Ser. No. 60/816,798 filed on Jun. 26, 2006,whereby all above listed applications are herein incorporated byreference.

It will now be apparent to those skilled in the art that otherembodiments, improvements, details, and uses can be made consistent withthe letter and spirit of the foregoing disclosure and within the scopeof this patent, which is limited only by the following claims, construedin accordance with the patent law, including the doctrine ofequivalents.

While the disclosure has been described in detail and with reference tospecific embodiments thereof, it will be apparent to one skilled in theart that various changes and modifications can be made therein withoutdeparting from the spirit and scope of the embodiments. Thus, it isintended that the present disclosure covers the modifications andvariations of this disclosure provided they come within the scope of theappended claims and their equivalents.

What is claimed is:
 1. A circumcision system for removing excessforeskin from a neonatal penis comprising: a ring component having ashaft with a ring at a proximal end, a tip at a distal end, and atapered section between the proximal end and the distal end, wherein thetapered section includes a tapered section end, wherein the ringcomprises a radially oriented clamping surface with a circumferentialgroove and an axially-oriented cutting surface; and a clamping-cuttingdevice comprising: a two-piece housing forming a bore having a open endat a proximal end and a closed end having a hole at a distal end whenassembled thereto, wherein the hole includes a diameter larger than adiameter of the tip of the shaft; a core section encased within the boreof the two-piece housing having an axially oriented blade disposed at aproximal end and a lever arm pivot point at a distal end; a lever armhaving an engagement tooth being pivotally attached to the lever armpivot point of the core section; a pair of safety latch mechanismspivotally attached to the core section, wherein the pair of safety latchmechanisms form a pre-actuation gap therebetween; wherein each safetylatch mechanism of the pair of safety latch mechanisms includes two endsand an inward oriented tab connected to at least one end of the two endsto engage the tapered section end of the ring component tapered sectionto retain the ring component in place relative to the two-piece housing;and an actuation mechanism disposed within the bore of the two-piecehousing comprising a plurality of longitudinal clamping arms at aproximal end of the actuation mechanism having inward radialprojections, wherein at least a portion of the plurality of longitudinalclamping arms being disposed outside the bore of the housing forming agap between the inward radial projections being greater than a diameterof the circumferential groove of the radially oriented clamping surfaceof the ring component; and a lever arm engagement gear tooth at a distalend of the actuation mechanism to engage the engagement tooth of thelever arm when the lever arm is actuated with the proper ring componentinserted therein.
 2. The circumcision system according to claim 1,wherein: the ring component further comprises a limiting section havinga first section with a first diameter and a first section length, asecond section with a second diameter greater than the first diameter,and a second section length; and wherein the core section furthercomprises a limiting section having a first section with a bore diametergreater than the first diameter of the first limiting section of theshaft to receive the shaft of the ring component there-through and afirst section depth, and a second section with a bore diameter greaterthan the second diameter of the second limiting section of the shaft anda second section depth, wherein the second section depth of the secondlimiting section of the core section is substantially equal to thesecond section length of the second limiting section of the ringcomponent.
 3. The circumcision system according to claim 1, wherein atleast one of the safety mechanisms of the pair of safety latchmechanisms comprises a safety latch to engage an aperture on an innersurface of the actuation mechanism; wherein the tapered section of thering component further comprises a first diameter smaller than thepre-actuation gap formed by the pair of safety latch mechanisms and asecond diameter greater than the pre-actuation gap formed by the pair ofsafety latch mechanisms such that at least one safety latch mechanism ofthe pair of safety latch mechanisms pivots to release the safety latchfrom the aperture on the inner surface of the actuation mechanism whenthe second diameter of the tapered section of the ring componentcontacts an end of the at least one safety latch mechanism of the pairof safety latch mechanisms.
 4. The circumcision system according toclaim 1, wherein at least one safety latch mechanism of the pair ofsafety latch mechanisms comprises a safety latch; and wherein theactuation mechanism further comprises an aperture on an inner surface ofthe actuation mechanism sized to retain the safety latch of the at leastone safety latch mechanism thereby retaining relative movement of theactuation mechanism with respect to the core section.
 5. Thecircumcision system according to claim 1, wherein the lever arm furthercomprises a slip gear tooth and wherein the actuation mechanism furthercomprises a slip gear tooth to engage the slip gear tooth of the leverarm when the lever arm is actuated for a clamping-cutting operation. 6.The circumcision system according to claim 1, wherein the two-piecehousing further comprises an extension attached to the proximal endhaving an outer surface that contacts body tissue as the neonatal penisis guided through a bore of the extension toward the housing to ensurethe penis is extended a predetermined distance.
 7. The circumcisionsystem according to claim 1, wherein each inward radial projection ofthe plurality of longitudinal clamping arms comprise a tongue and agroove such that the tongue of an inward radial projection is receivedwithin the groove of an adjacent inward radial projection to form acircumferentially overlapping configuration therewith and noradial-through gap therebetween when the plurality of longitudinalclamping arms are in a pre-clamp position to prevent foreskin migratingbetween the inward radial projections during a clamping operation andpinching the foreskin.